Detection and Characterization of Sessile Serrated Lesions (SSL) of the Right Colon
试验速览
- 阶段
- 不适用
- 入组人数
- 71
- 试验地点
- 6
- 主要终点
- patients with sessile serrated lesions
研究概览
简要总结
There are a few studies regarding Sessile Serrated Lesions (SSL). They are recently identified as precancerous lesions. Yet, digestive tract serrated lesions would be part of a new colic carcinogenesis way : the serrated tumor way. Evolution from polyp to cancer would be faster than through the usual adenoma to cancer way. It would be then responsible of a lot of "missed" lesions or interval cancer. The missed SSL rate is estimated at between 27% and 59%.
Current diagnosis methods show weakness to identify those SSL. In order to improve their detection, the investigators dispose of several coloration techniques. Indigo carmine chromoendoscopy enhance neoplastic lesion detection as part of the hereditary rectal carcinoma screening. NBI electronic coloration, which is faster and easier has not shown any efficacy on the adenoma detection rate, except for patients with Lynch syndrome.
The objective is to better describe the SSL endoscopic semiology (detection and characterization) and to establish standards for the endoscopic techniques in order to improve the colonoscopy diagnosis quality. The investigators propose to evaluate 2 fundamental endoscopic techniques (Narrow Band Imaging (NBI) and indigo carmine), widely used for other indications, in comparison with the White Light technique (WLI).
Therefore, the investigators propose a prospective, observational, multicentric cohort study in order to 1) define SSL endoscopic various aspects 2) establish which technique (white light, Narrow Band Imaging, indigo carmine chromoendoscopy) is the best to diagnose SSL, namely detection and characterization 3) evaluate the multifocal dimension rate for those lesions at ascending colon level.
The diagnosis impact is immediate, and could allow to consider an update for boh endoscopic NICE and Kudo Pit Pattern classification, and good practice guidances for colonoscopic diagnosis. Better SSL detectability thus their systematic resection could have a long term effect in reducing both colon cancer rate and interval cancer
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 18 years of age or older
- •Patient having an indication for colonoscopy to detect colorectal neoplastic lesions, which meet at least one of the following conditions :
- •Positive fecal occult blood test
- •1st degree family history of colorectal cancer or adenoma before 60 years of age
- •Personal history of colorectal adenoma or colorectal cancer
- •Unexplained digestive symptoms after 50 years of age or those not responding to symptomatic treatment : modification of bowel movements, abdominal pains
- •Isolated or repeated rectal bleeding after 50 years of age or occult bleeding
- •Acromegaly
- •Infectious endocarditis with digestive bacteria
- •Suspicion of sessile serrated lesion in the right colon
- •None opposite of patient for participating
排除标准
- •History of digestive resection as resection of the right colon (right ileocolectomy, right hemicolectomy) or large colic resection.
结局指标
主要结局
patients with sessile serrated lesions
时间窗: at colonoscopy day (Day 1)
Proportion of patient for whom at least one new SSL has been shown macroscopically through NBI and/or indigo carmine chromoendoscopy but not detected with WLI
次要结局
- PARIS classification(at colonoscopy day (Day 1))
- Specific mean of macroscopically detected SSL(at colonoscopy day (Day 1))
- False negative(histopathological results (up to 2 weeks))
- False positive(histopathological results (up to 2 weeks))
- Kudo's pit pattern classification(at colonoscopy day (Day 1))
- SSL histologic characterization(histopathological results (up to 2 weeks))
- NICE classification(at colonoscopy day (Day 1))
- Detection techniques diagnosis performance(at colonoscopy day (Day 1) + histopathological results (up to 2 weeks))